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Wednesday, October 5, 2016

Helsinn v. Teva Oral Argument Recap

Posted by
Lisa Ouellette

In March, I posted about an amicus brief filed by 42 IP profs in Helsinn v. Teva, which argued that contrary to the district court's opinion and position taken by the USPTO, the America Invents Act (AIA) did not change the meaning of "on sale" and "public use" in 35 U.S.C. § 102(a)(1). The case was argued yesterday before the Federal Circuit, and the panel (Judge Dyk, Judge Mayer, and Judge O'Malley) didn't seem eager to conclude that the AIA wrought a significant change.

The appeal involves Teva's challenge to Helsinn's post-AIA patent on the nausea drug palonosetron, which was filed over a year after a secret licensing and supply contract for the drug. In Pfaff v. Wells Electronics (1998), the Supreme Court held that the on-sale bar applies when a product is (1) "the subject of a commercial offer for sale" and (2) "ready for patenting" as of the critical date (one year before filing). Both issues are contested here, as the district court said that the drug was neither ready for patenting nor on sale within the meaning of the post-AIA § 102. I'll focus here just on the AIA issue, but note that Judge O'Malley asked about remanding for further factfinding and whether it is necessary to reach the AIA issue.

The only line of questioning on the AIA issue for Teva was Judge Dyk's criticism of the dueling canons of statutory interpretation for figuring out what "or otherwise available to the public" means in the new § 102. Teva argued that under the "last antecedent" canon, "to the public" modifies only "otherwise available"; Helsinn countered that under the "series qualifier" canon, the concluding phrase "otherwise available to the public" qualifies everything in the series, including "on sale." But Judge Dyk stated that neither canon can apply because the modifier would be "available to the public," leaving just the word "otherwise," which doesn't make sense. Teva pivoted to its argument that "or otherwise available to the public" is a catchall category for new technologies, which the panel seemed comfortable with; Judge Dyk suggested "an oral description at a conference" as something that might fall into this bucket.

The United States argued in support of Helsinn on the AIA issue, contending that only sales that make an invention available to the public trigger the on-sale bar, and that the AIA merely confirmed that this was already the rule pre-AIA. Judge Dyk was not convinced by the government's use of legislative history:

You rely on all this legislative history, but aside from one statement by Senator Kyl, it's all kind of ambiguous as to what they're talking about in terms of a public sale. In other words, here we have a sale which was public, and the only thing that wasn't known was the exact formulation, and it's not at all clear that that kind of distinction was something that was apparent to the senators and representatives who were speaking about this, right?

The government also faced tough questioning from both Judge Dyk and Judge O'Malley on the workability of its proposal, and it significantly backed off from the position in its brief:

United States: We believe that the existence of a confidentiality agreement is certainly relevant to the question of whether or not it makes the invention available to the public, but it's not dispositive. . . .Judge O'Malley: That's not really what you argued in your brief. You argued that secret sales simply should be excluded.United States: Sure, Your Honor, and I apologize if our briefing on that point was imprecise.

After the lawyer for the United States refused to agree that under Pfaff, a single non-confidential sale must be sufficient to trigger the pre-AIA bar—stating that "it depends on a number of factors"—Judge Dyk called the proposed rule "completely unworkable."

At the end, the government even backed off committing to how the rule should apply to Helsinn: "If this court concludes that this was in fact a sale that made the invention available to public, that will not cause us any heartburn." So one option here is for the Federal Circuit to say that both pre- and post-AIA sales must be available to the public, but only under the special definition of that phrase for patent law, under which "public" includes things that lay observers wouldn't consider very public at all.